Medical Writer (f/m/d) (369821/001) Hamburg, Germany

Harvey Nash GmbH supports many of Germany's leading organisations to source, recruit and manage the highly skilled IT and engineering talent they need to succeed in an increasingly technology-driven world.

We offer some of the most interesting and challenging roles where you get to work with the latest IT Technologies with some of the biggest clients in Germany.

For our client in Hamburg area we are looking for a Medical Writer on a freelance basis (f/m/d)
Project start: ASAP
Project duration: 10 months +
Location: Hamburg area 

Tasks:

• Facilitate and prepare high quality clinical and regulatory documentation, within established timelines, to implement and support clinical and regulatory operations
• Prepare clinical and regulatory documents within established timelines that are of high quality in terms of scientific content, data interpretation, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines
• Interact effectively with project and functional team leaders, clinical leaders, project physicians, statisticians, programmers, regulatory personnel, nonclinical scientists etc., and proactively initiate and/or facilitate effective interactions and information exchange/communication among coauthors/reviewers as appropriate (including problem-solving and resolution of issues).
• Take an active role on assigned projects with respect to planning of content, format, and timing of documents, scheduling/tracking, etc. Initiate, schedule and facilitate appropriate activities (host/chair meetings etc.) to plan and discuss logistics of document assembly.
• Support and coordinate the activities of the assigned project and clinical development teams to ensure project needs and departmental standards are met, while completing documents within established timelines.
• Keep abreast of project status, clinical operating plans, and ongoing/new studies as well as scientific literature within active project areas.
• Maintain/develop current knowledge of regulatory guidelines, technological advances, and industry standards by sourcing and attending relevant training programs.

Skills:

• 5y+ experience in Medical and Regulatory Writing
• Strong background in Communication Management
• German & English spoken and written

If you are interested in this vacancy, we would be pleased to receive your updated CV, availability and your salary expectations.
Please feel free to contact me if you have any questions.
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